| Position | Ethics and Regulatory Specialist |
| Department | Clinical Trials Unit |
| Location | Oxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam |
| Hours of work | Full-time. Working hours are 37.5 hours per week. |
| Tenure | Initially for 1 year, including a 2-month probation period, with the possibility of extension. |
| Reporting to | Ethics Team Leader |
| Vacancy reference | JD-0923-029 |
| Background | The Oxford University Clinical Research Unit (OUCRU) is a large-scale clinical and public health research unit, with sites offices in Ho Chi Minh City and Hanoi in Vietnam, Jakarta in Indonesia and Kathmandu in Nepal. In Vietnam, we are hosted by the Hospital of Tropical Diseases (HTD) in Ho Chi Minh City, and the National Hospital for Tropical Diseases (NHTD) in Hanoi. OUCRU Nepal has partnerships with the Patan Academy of Health Sciences and Patan Hospital, and OUCRU Indonesia exists in partnership with the University of Indonesia. As a Wellcome Trust Africa Asia Programme, we have received considerable support from the Wellcome Trust since our establishment in 1991. OUCRU’s vision is to have local, regional and global impact on health by leading a locally driven research programme on infectious diseases in Southeast Asia. Priority is given to health issues important to the hospitals where we work, and to the countries as a whole where we operate: Vietnam, Indonesia and Nepal. All work is intended not only to benefit the patients seen daily at our host hospitals, but also to help improve patient care. OUCRU employs approximately 320 people across Viet Nam and has an average annual budget of USD 12mil. Please see more information on OUCRU website: www.oucru.org |
| Job summary | An Ethics and Regulatory Specialist will support studies through the required ethical and regulatory approvals, help to prepare study documentation, track study progress, maintain approvals/documentation during the study, and liaise with the study sites to ensure the study is run in compliance with international guidelines and local regulations. The post holder will contribute to the continued growth and development of the CTU team |
| Key responsibilities and tasks | 1. Responsible for conducting all Science and Ethics committee submissions: o Conducting protocol and study documents pre-reviews: § Work with the trial staff for each new study to ensure the protocol and procedures comply with the applicable local and international regulatory standards. § Review clinical trial protocols in order to identify inconsistencies, errors and omissions. o Conducting the submission and tracking of regulatory and ethical applications for clinical research to relevant local and international bodies. o Being key contact to communicate IRB decisions and rationale to investigators. o Maintain regulatory filing of essential documents for each study in accordance with the principles of Good Clinical Practice. 2. Maintain an up-to-date understanding of clinical trial regulations and ethics, both local and international. o Provide consultation/ education to investigators and research staff about the updated knowledge of human subject protection regulations and institutional policies. o Provide guidance to staff regarding the policies of the Clinical Trials Unit and implementation of those policies. 3. Support the SAE reporting procedure, help PIs and coordinators to liaising with local ECs and MoH to send the SAE reports as required by the local ECs and MoH guideline 4. Contribute in the development of study and site procedures for good research governance. 5. Help study staff to develop appropriate ways to document all processes in a research study 6. Act as the primary contact for local and national regulatory bodies regarding clinical trials. 7. Perform general administrative duties as needed. 8. Verify study document translation (English – Vietnamese) 9. Contribute to the development of CTU systems, procedures and documentation, especially those relating to governance processes. 9. Attend career training to improve skills and update relevant knowledge 10. Assist actively with the organization and delivery of training in the guidelines of Good Clinical Practice 11. Other tasks as required. |
| Selection criteria | Essential criteria: · Degree in Science, Pharmacy, Medicine, Nursing, Public Health or related field. · Excellent Vietnamese and English language skills. · Proven oral and written presentation skills. · Excellent diplomatic communication and interpersonal skills. · High level of organizational and record-keeping skills. · Understanding of ICH-GCP guidelines, local and international regulations on clinical research. · Self-starter, detail-oriented, good time management, problem solver, flexible and adaptable, self-confident Preferred criteria: · Experience in conducting, coordinating, monitoring or quality-assuring of clinical research. |
| Benefits | · Contracted salary: Negotiable (depending on actual experience and education). · Optional insurance: In-patient and out-patient medical coverage; Personal accident insurance coverage · Two months’ salary for annual bonus and clothes · Annual leave 18 days each year for the first year · Other responsibilities and benefits are based on Viet Nam Labor Law. |
| How to apply | Interested qualified candidates are invited to send their detailed resume and cover letter in English, including copies of relevant degrees, certificates, either by email or by post to the following address: Oxford University Clinical Research Unit Laboratory of Clinical Science Hospital for Tropical Diseases 764 Vo Van Kiet, Ward 1, District 5, HCMC Tel: 39237954 Email: hr@oucru.org *** We thank all candidates for their interest but only short-listed applicants will be notified for interview. |
| Contact person | Ms Nguyen Thi Hong Phuc |
| Deadline for submission | 21st Sep 2023 |
